PRINCIPAL: A prospective observational study of real world treatment patterns and treatment outcomes in patients with advanced or metastatic renal cell carcinoma receiving pazopanib (115232)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Prospective observational study
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective observational study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  PAZOPANIB

Population studied

• Short description of the study population:
  Patients with advanced or metastatic renal cell carcinoma (RCC) treated for the first time with pazopanib.; Patients with following criteria were included:; 1. Age 18 years or older at enrollment; 2. Documented diagnosis of advanced and/or metastatic clear cell or predominantly clear cell RCC; 3. Clinical decisionmade to initiate treatment with pazopanib prior to enrollment in the study, but within 30 days of enrollment
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To evaluate overall survival (OS), progression-free survival (PFS) and the overall response rate (ORR) in patients treated with pazopanib
• Data analysis plan:
  For the analysis of overall survival, the last date of known contact will be used for those patients who have not died at the time of analysis. For the analysis of progression-free survival (PFS), if the patient received subsequent anticancer therapy prior to the date of documented progression or death, progression free survival will be censored at the last adequate assessment (e.g. assessment where visit level response is complete response, partial response or stable disease) prior to the initiation of therapy. The overall response rate (ORR) will be based on the investigator assessment of overall response in the Measurable Disease (MD) population.

Documents

Study results

PZP034A2401 CSR_Redacted_PDF_A